← Product Code [OLO](/productcode/OLO) · K192653 # Perseus (K192653) _Orthokey Italia S.R.L. · OLO · Sep 9, 2020 · Neurology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K192653 ## Device Facts - **Applicant:** Orthokey Italia S.R.L. - **Product Code:** [OLO](/productcode/OLO.md) - **Decision Date:** Sep 9, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4560 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for Use PERSEUS is a computer-controlled system, intended to assist in distal femoral resection and tibial resection during Total Knee Arthroplasty, determining reference alignment axes in relation to anatomical and instrumentation structures during stereotaxic orthopaedic surgical procedures. ## Device Story Perseus is a computer-assisted stereotaxic system for Total Knee Arthroplasty. It uses triaxial accelerometers and gyroscopes attached to surgical instruments to track limb movement and orientation. The system calculates and displays angular/positional changes in a triaxial format on a graphical user interface located outside the sterile field. Surgeons use this real-time data to establish mechanical axes of the femur and tibia, determining varus/valgus and flexion/extension angles for cutting blocks. By guiding precise resection, the device aims to improve final limb alignment and reduce blood loss compared to conventional mechanical instrumentation. It is intended for professional use in operating rooms. ## Clinical Evidence Evidence includes bench testing, pre-clinical simulated OR studies, and European clinical evaluations. Studies compared Perseus against conventional techniques and navigation systems. Results showed Perseus achieved HKA alignment within 3° and femoral distal resection within 2° of deviation. A study of 53 patients showed an average HKA alignment deviation of 0.7° (range 0-2°). Additional data from 20 cases showed femoral resection alignment of 91±0.5° varus and tibial slope of 0.1±1.7°. Clinical metrics included final limb alignment, blood loss, and surgical time. ## Technological Characteristics System comprises a non-sterile computer unit, navigation/measurement software, reusable instruments, and single-use sensors. Uses triaxial accelerometers and gyroscopes for orientation sensing. Powered by DC battery. Materials include stainless steel and polymers common to orthopedic instruments. Sterilization: EO for navigation unit, autoclave for instruments. Complies with IEC 60601-1 and IEC 60601-1-2. ## Regulatory Identification A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. ## Predicate Devices - KneeAlign 2 System ([K163379](/device/K163379.md)) ## Reference Devices - iASSIST™ Knee System ([K141601](/device/K141601.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 9, 2020 Orthokey Italia S.r.l. % Guido Bonapace Regulatory Affair Isemed srl Via P. Togliatti, 19/X Imola, 40026 Italy Re: K192653 Trade/Device Name: Perseus Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 6, 2020 Received: August 10, 2020 Dear Guido Bonapace: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192653 Device Name PERSEUS Indications for Use (Describe) PERSEUS is a computer-controlled system, intended to assist in distal femoral resection and tibial resection during Total Knee Arthroplasty, determining reference alignment axes in relation to anatomical and instrumentation structures during stereotaxic orthopaedic surgical procedures. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| |
Prescription Use (Part 21 CFR 801 Subpart D)
|
Over-The-Counter Use (21 CFR 801 Subpart C)
| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted as required by 21 CFR 807.92. #### 5.1 General Information | Submitter : | ORTHOKEY Italia S.r.l | |-------------|--------------------------| | | Piazza Nazioni Unite, 15 | | | 54033 Carrara (MS)-Italy | | | Tel. +39 055 354829 | | | Fax +39 055 3246012 | Consultant/ Contact: Guido Bonapace ISEMED srl Via Palmiro Togliatti 19/X Imola, BO 40026 ITALY Tel. +39 0542 683803 Fax +39 0542 698456 Email: regulatory@isemed.eu Summary Prepared Date: September the 7th, 2020 #### 5.2 Names | Device Name: | PERSEUS | |------------------|-----------------------------------| | Common Name: | Orthopedic Stereotaxic Instrument | | Regulation Name: | Stereotaxic Instrument | | Product Code: | OLO | | Classification: | 21 CFR 882.4560, Class II | #### 5.3 Predicate Devices The medical device PERSEUS is substantially equivalent to the following device legally marketed in the US: | Applicant | PREDICATE Device name | 510(k) Number | |----------------|-----------------------|---------------| | OrthAlign Inc. | KneeAlign 2 System | K163379 | Moreover, the following reference device has been considered: | Applicant | REFERENCE Device name | 510(k) Number | |------------|-----------------------|---------------| | Zimmer CAS | iASSIST™ Knee System | K141601 | {4}------------------------------------------------ ### 5.4 Device Description PERSEUS is a computer assisted system, that helps surgeon in the positioning of implant components, during total knee implant surgical procedure, according to the conventional reference axes in relation to anatomical landmarks. Perseus System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The device assists the surgeon in: - Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur. - Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia. Perseus system utilizes triaxial accelerometer and triaxial gyroscope to determine, through limb movement, reference axes of femur and tibia and relative orientation of distal femoral and tibial cutting guide with respect to frontal and sagittal planes of the limb. #### 5.5 Indications for Use PERSEUS is a computer-controlled system, intended to assist in distal femoral resection and tibial resection during Total Knee Arthroplasty, by determining reference alignment axes in relation to anatomical and instrumentation structures during stereotaxic orthopedic surgical procedures. | | Proposed Device | Predicate Device | Reference Devices | |------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | PERSEUS | KneeAlign 2 System | iASSIST Knee System | | Manufacturer | Orthokey Italia S.r.l. | OrthAlign Inc. | Zimmer CAS | | 510(K) No. | | K163379 | K141601 | | Classification
Name | Orthopedic Stereotaxic
Instrument | Orthopedic Stereotaxic
Instrument | Orthopedic Stereotaxic
Instrument | | Figure | Image: PERSEUS | Image: KneeAlign 2 System | Image: iASSIST Knee System | | Regulation
Number | 882.4560 | 882.4560 | 882.4560 | | Regulatory Class | II | II | II | | Classification
Product Code | OLO | OLO | OLO | | Intended use | | | | | Indications for
use | PERSEUS is a computer-
controlled system, intended
to assist in distal femoral
resection and tibial | The OrthAlign Plus®System is a
computer-controlled system
intended to assist the surgeon
in determining reference | The iASSIST Knee System is a
computer assisted stereotaxic
surgical instrument system to
assist the surgeon in the | | | Proposed Device | Predicate Device | Reference Devices | | Product Name | PERSEUS | KneeAlign 2 System | iASSIST Knee System | | | resection during Total Knee
Arthroplasty, by
determining reference
alignment axes in relation to
anatomical and
instrumentation structures
during sterotactic
orthopaedic surgical
procedures. | alignment axes in relation to
anatomical structures during
stereotactic orthopedic surgical
procedures. The KneeAlign
system facilitates the accurate
positioning of implants and
instrumentation, relative to
these alignment axes.
Orthopedic surgical procedures
include but are not limited to:
Total Knee Arthroplasty
Unicompartmental Knee
Arthroplasty – Tibial Transverse
Resection | positioning of orthopedic
implant system components
intra-operatively. It involves
surgical instruments and
position sensors to determine
alignment axes in relation to
anatomical landmarks and to
precisely position alignment
instruments and implant
components relative to these
axes. Example orthopedic
surgical procedures include
but are not limited to: Total
Knee Arthroplasty. | | Target
population | Orthopedic surgical
procedures include:
Total knee arthroplasty | Orthopedic surgical procedures
include but are not limited to:
Total Knee Arthroplasty
Uni-compartmental Knee
Arthroplasty - Tibial Transverse
Resection | Orthopedic surgical
procedures include but are
not limited to:
Total knee arthroplasty | | Anatomical site | knee | knee | Knee | | Where used
(hospital, home,
ambulance, etc) | For professional use in
operating room | For professional use in
operating room | For professional use in
operating room | | Technology | | | | | Energy used
and/or
delivered | • Navigation unit, reference
sensor: DC battery power.
• Instruments: manual
position and orientation | • Navigation unit, reference
sensor and laser module: DC
battery power
• Instruments: manual position
and orientation | • Reference sensor: DC
battery power.
• Instruments: manual
position and orientation | | User Interface | Graphical user interface, on
computer unit, outside
sterile field. | Integrated graphical user
interface, on an electronic unit
that attaches to
instrumentation. | Integrated graphical user
interface, on an electronic
unit that attaches to
instrumentation. | | Control
Mechanism | Computer generation of
positional information, using
inertial sensors,
microcontroller, digital
signal processor and
physical positions of
registration instruments. | Computer generation of
positional information, using
inertial sensors,
microcontroller, digital signal
processor and physical
positions of registration
instruments. | Computer generation of
positional information, using
inertial sensors,
microcontroller, digital signal
processor and physical
positions of registration
instruments. | | Operating
Principles
Registration of
anatomy | Electronics attached to
movable instruments,
placed in specified
procedural positions, for
recording sensor data. | Electronics attached to movable
instruments, placed in specified
procedural positions, on or in
contact with bony anatomy, for
recording sensor data. | Electronics attached to
movable instruments, placed
in specified procedural
positions, on or in contact
with bony anatomy, for
recording sensor data. | | Measurement
of change in
angular
orientations | • Computer displayed
values based on internal
calculations.
• Accelerometer | • Computer displayed values
based on internal calculation.
• Accelerometer measurement
of angular change in | • Computer displayed values
based on internal
calculation.
• Accelerometer | | | Proposed Device | Predicate Device | Reference Devices | | Product Name | PERSEUS | KneeAlign 2 System | iASSIST Knee System | | | change in instrument
positions. | | change in instrument
positions. | | Patient interface | Instrument fixation to bone
with pins or screws.
Instrument indications and
engagement of bony
anatomy via physical surface
contact | Instrument fixation to bone
with pins or screws. Instrument
indications and engagement of
bony anatomy via physical
surface contact | Instrument fixation to bone
with pins or screws.
Instrument indications and
engagement of bony anatomy
via physical surface contact | | Main System
Components | • Non sterile reusable
computer unit
• Navigation and
measurement software
• Reusable instrument sets
• Single-use sensor | • Single-use computer unit
• Navigation and measurement
software
• Reusable instrument sets | • Non sterile reusable
computer unit
• Navigation and
measurement software
• Reusable instrument sets
• Single-use sensor | | Performance | HKA angle within 3° | HKA angle within 3° | HKA angle within 3° | | Electrical Safety
and EMC | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 | | Materials | Stainless Steel grades
common to orthopedic
surgical instruments
Polymer grades common to
orthopedic surgical
instruments
Internal electronics | Stainless Steel grades common
to orthopedic surgical
instruments
Polymer grades common to
orthopedic surgical instruments
Internal electronics | Stainless Steel grades
common to orthopedic
surgical instruments
Polymer grades common to
orthopedic surgical
instruments
Internal electronics | | Biocompatibility | Per ISO 10993-1, External
Communicating Device,
Tissue/Bone/Dentin
Communicating, with
subsystems that have
potential indirect contact
for a limited contact
duration (< 24 hours) | Per ISO 10993-1, External
Communicating Device,
Tissue/Bone/Dentin
Communicating, with
subsystems that have direct
and potential indirect contact
for a limited contact duration (< 24 hours) | Per ISO 10993-1, External
Communicating Device,
Tissue/Bone/Dentin
Communicating, with
subsystems that have direct
and potential indirect contact
for a limited contact duration
(< 24 hours) | | Compatibility
with the
environment
and other
devices | Specified storage and
operating environments for
typical transport and
surgical environments. | Specified storage and operating
environments for typical
transport and surgical
environments. | Specified storage and
operating environments for
typical transport and surgical
environments. | | Sterilization | • Navigation unit: EO
sterilization.
• Instruments: autoclave
sterilization | • Navigation unit: EO
sterilization.
• Instruments: autoclave
sterilization | • Navigation unit: EO
sterilization.
• Instruments: autoclave
sterilization | ### 5.6 Comparison with the predicate and the reference device {5}------------------------------------------------ {6}------------------------------------------------ ## ORTHOKEY ITALIA SRL 510(K) PREMARKET NOTIFICATION The subject device PERSEUS fall under the same Regulation number, Regulatory Class and Product Code as the predicate device K163379 and the reference device K141601. The indication for use of the subject device PERSEUS is similar to the one declared by the predicate device K163379 and the reference device K141601. As per information provided in the table above, the technical and performance features of the proposed and predicate devices are similar or identical. In order to demonstrate the effective comparison related to clinical performance, biocompatibility, sterilization, packaging, shelf life, electrical and EMC safety, specific clinical evaluation and tests based on international standards have been performed. {7}------------------------------------------------ In light of evidence listed in the table above, the proposed device PERSEUS can be considered substantially equivalent to the predicate device K163379 and the reference device K141601. #### 5.7 Performance Data In order to demonstrate the accuracy and repeatability of the proposed device PERSEUS in terms of alignment of the resection level, with respect to mechanical axis, performance tests have been conducted. Bench tests performance evaluation of Perseus has been done, verifying the orientation of femoral or tibial resections. Clinical evaluation has been done with the same performance requirement when possible or, in alternative, looking at final leg alignment with post-operative x-rays. The clinical evaluation has been prepared considering: - Bench testing - Pre-clinical evaluation testing - Aftermarket Clinical evaluation (Europe) - Data generated from literature Bench testing have been conducted introducing controlled variables within an appropriate test setup throughout the subject device's operational range, to quantify the accuracy of the device. A set of bench tests have been designed in order to: - Verify the measurement repeatability on a controlled setup, with different cursor positions of the jig - Verify the error introduced by mispositioning of the ankle instrumentation - Verify the repeatability of the measurement with different sensors - Verify the repeatability of the measurement with different instrument positioning Pre-clinical activities have been conducted to verify accuracy, repeatability and reproducibility in a simulated OR setup and to verify the consistency of the procedure when performed by different users with different level of experience. Aftermarket clinical evaluation. Since Perseus is CE marked, aftermarket clinical evaluation has been done in Europe. Studies were conducted involving research centers in order to verify clinical results and performances of Perseus. A study involved 3 cohorts of 10 patients each randomly selected, operated by the same surgical equipe, where perseus was used only for distal femoral resection. The cohorts were dividend in: - EM Perseus; patients operated with Perseus ● - EM Nav; patients operated with surgical navigation system, - IM Conv; patients operated with conventional mechanical instrumentations. Final limb alignment on frontal and lateral planes and blood loss have been measured postoperatively. Perseus has demonstrated to fulfil surgical goal of final HKA alignment within 3° of deviation and femoral distal resection within 2° of deviation, and a reduced blood loss, compared to conventional technique. A second study only on femoral resection has been performed on a multicentric study involving two centers. The goal of the study was to verify blood loss and angular deviation of femoral distal resection on frontal and lateral planes, for two cohorts of 18 patients: 1 operated with the use of Perseus; 2 operated with conventional instrumentation. Perseus for the femoral resection has confirmed to satisfy the requirements of have a deviation < 2° in both frontal and lateral planes. A third study was a single cohort evaluation, on 20 patients, of final limb alignment, blood loss and surgical time. Results show an average femoral resection alignment of 91±0.5° varus in frontal plane and 1.5±1.0° on sagittal plane. {8}------------------------------------------------ Data on post-operative x-rays obtained from first 20 cases performed by the same user have been obtained. Results show an average post-operative deviation of HKA angle of 0.3±1.5°, femoral implant flexion of 0.8±0.8° and a tibial slope of 0.1±1.7°. Data on post-operative x-rays obtained from 53 patients operated with Perseus and compared with 52 patients operated with conventional technique have been obtained. Results show and average post-operative deviation of HKA alignment of 0.7° with a range of 0-2°. ### 5.8 Conclusion The comparison performed between the proposed device PERSEUS, the predicate device K163380 and the reference device K141601, is able to demonstrates that the device PERSEUS has similar technical features and clinical performance of the devices previously marketed in US. Particularly, even if the user interface is slightly different from the one proposed by the predicate device, this difference does not raise any new concern in terms of safety and effectiveness, as demonstrated through electrical safety, EMC, sterilization, packaging, shelf life and performance test reports. In light of evidence summarized above and based on classification, intended use, technological characteristics, and performance data, the subject device PEPRSEUS may be found substantially equivalent to the predicate device KneeAlign 2 System (K163379) and the reference device iASSIST™ Knee System (K141601). --- **Source:** [https://fda-staging.innolitics.com/device/K192653](https://fda-staging.innolitics.com/device/K192653) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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